Director, Regulatory & Compliance

Absci

. Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms .

Posted 9/17/2026full-timeRemote • United StatesLead💰 $195,000 - $240,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in building and maintaining ethics and compliance programs, with a strong focus on regulatory strategy, particularly in FDA and GDPR compliance. Proven ability to lead cross-functional collaboration and manage complex regulatory interactions and audits.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA SubmissionsGDPR ComplianceData Governance FrameworksStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentCompliance Program BuildingInternal InvestigationsData Privacy LawAI/ML Regulatory Considerations

Soft Skills

Strong CommunicationSelf-StarterCollaboration

Tools & Technologies

DPIAsROPAsIncident Response Protocols

Certifications & Qualifications

Bachelor's DegreeAdvanced Degree (JD, MS, PharmD)

Industry Keywords

BiotechPharmaRegulated IndustryCompliancePrivacy Governance

About the role

Key responsibilities & impact

Build and maintain the company's ethics and compliance program, including policies, training, monitoring, and reporting mechanisms
Develop and execute regulatory strategy across the product development and commercial lifecycle, focusing on FDA and applicable international authorities such as EMA and ICH
Monitor evolving regulatory and legislative landscapes, including AI/ML guidance, data privacy law, and biotech-specific frameworks, and assess business impact
Serve as primary liaison for regulatory agency interactions, submissions, and inspections
Lead internal investigations and audits, and manage corrective action and remediation processes
Develop and implement a GDPR-ready data governance framework, including DPIAs, ROPAs, and data subject rights mechanisms
Establish privacy-by-design principles across product and platform development with Engineering and Product teams
Ensure privacy governance structures across jurisdictions where Absci operates or processes personal data
Lead vendor and third-party data protection due diligence, including DPAs and sub-processor compliance
Maintain incident response and breach management protocols satisfying GDPR's 72-hour notification window
Report regulatory, compliance, privacy program status, and GDPR readiness metrics to the CLO, Board, or external stakeholders
Collaborate with Legal, Quality, IT, and Clinical teams to embed compliance into business operations

Requirements

What you’ll need

14+ years of experience spanning regulatory affairs and/or compliance in biotech, pharma, or a related regulated industry
Hands-on experience with FDA submissions and agency interactions; international regulatory experience a plus
Ability to build or significantly scale a compliance program
Comfortable operating without a large team; a builder and self-starter who thrives in a fast-paced environment
Strong communication skills, including translating regulatory complexity for non-specialist stakeholders and executives
Bachelor's degree in a scientific or legal discipline; advanced degree (JD, MS, PharmD) preferred
Experience in a clinical-stage or early-commercial biotech environment is nice to have
Familiarity with AI/ML in drug discovery regulatory considerations is nice to have
Government affairs or policy engagement experience is nice to have
Legal authorization to work in the United States is required

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Unlimited vacation
Parental leave
Employee assistance program
Voluntary life insurance
Voluntary disability insurance
Annual bonus potential
401(k) with a generous company match
Equity